The Turkish Version of the Shanghai Elbow Dysfunction Score

March 6, 2022 updated by: Tansu Birinci, Istanbul University-Cerrahpasa

The Reliability and Validity of the Turkish Version of the Shanghai Elbow Dysfunction Score

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate elbow function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties.

Study Overview

Status

Completed

Conditions

Detailed Description

The Shanghai Elbow Dysfunction Score (SHEDS) is originally developed in English to evaluate joint function in patients with elbow stiffness. The purpose of this study is to translate and cross-culturally adapt the SHEDS instrument into Turkish and investigate its psychometric properties. Approximately seventy patients with elbow limitation will be included. For cross-cultural adaptation, two bi-lingual translators will use the back-translation procedure. Within a 3-to-5-day period after the first assessment, the participants will complete the Turkish version of SHEDS (SHEDS-T) to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlation with the Turkish version of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, the Turkish version of Mayo Elbow Performance Score, and Short Form-12 will be determined to check the validity. Responsiveness and floor and ceiling effects will be detected.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Bakırkoy
      • Istanbul, Bakırkoy, Turkey, 34147
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All participants are patients who had sustained an elbow fracture and are treated surgically. The participants with elbow stiffness after an elbow fracture are directed for assessment following a confirmation by an orthopaedist that the bone fracture healed based on the physical examinations and diagnostic imaging.

Description

Inclusion Criteria:

  • Aged between 20 and 55 years
  • Elbow fracture in the six months before the study
  • Elbow limitation in flexion or extension
  • Fractures should be managed with surgically
  • Being able to follow simple instructions
  • Being able to read and write in Turkish

Exclusion Criteria:

  • Malunion or Nonunion Fracture
  • The occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
  • Non-healing wound or infection
  • Previously received physiotherapy for elbow limitation
  • Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
  • Shoulder, elbow or wrist movement limitation in contralateral upper extremity or absence of limbs in the contralateral upper extremity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Shanghai Elbow Dysfunction Score (SHEDS)
Time Frame: Baseline (First assessment)
The Shanghai Elbow Dysfunction Score (SHEDS) is composed of 12 items and developed in 3 parts: elbow motion capacities, elbow-related symptoms, and patient satisfaction level. The SHEDS is a comprehensive and valid scoring system to evaluate elbow function in patients with elbow stiffness.
Baseline (First assessment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form-12 (SF-12)
Time Frame: Baseline (First assessment)
Short Form-12 (SF-12), which is developed based on Short Form-36, consists of 12 items: 7 items dealing with the physical components scores (PCS-12) and 5 items related to the mental components scores (MCS-12) of SF-12. Range of both scores is 0 to 100, where the higher scores indicate better health related quality of life.
Baseline (First assessment)
The Shanghai Elbow Dysfunction Score (SHEDS)
Time Frame: Within a 3-to-5-day period after the first assessment (Second assessment)
The Shanghai Elbow Dysfunction Score (SHEDS) is composed of 12 items and developed in 3 parts: elbow motion capacities, elbow-related symptoms, and patient satisfaction level. The SHEDS is a comprehensive and valid scoring system to evaluate elbow function in patients with elbow stiffness. The cumulative score is ranged from 0 to 100, where the higher scores indicate an increased level of function.
Within a 3-to-5-day period after the first assessment (Second assessment)
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
Time Frame: Baseline (First assessment)
The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire 30 core questions and optional additional 8 questions that are scored on a 5-point Likert-type scale (no difficulty-unable). The cumulative DASH score is ranged from 0 to 100, where the higher scores indicate an increased degree of disability.
Baseline (First assessment)
Mayo Elbow Performance Score (MEPS)
Time Frame: Baseline (First assessment)
Mayo Elbow Performance Score (MEPS) is designed to measure pain, stability, range of motion and the patient's ability to accomplish functional tasks, is one of the most commonly used physician based and joint-specific elbow rating system The cumulative MEPS score is ranged from 0 to 100, where the higher scores indicate an increased level of function.
Baseline (First assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University-Cerrahpasa

Investigators

  • Principal Investigator: Tansu Birinci, PhD, Istanbul Medeniyet University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2021

Primary Completion (Actual)

September 1, 2021

Study Completion (Actual)

March 7, 2022

Study Registration Dates

First Submitted

April 30, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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